Quality Control Analyst II
76 New York Ave, USMA0118 Framingham, MA
The Quality Control department supports the Seprafilm (medical device) and Sodium Hyaluronate (active pharmaceutical ingredient) GMP operations at the Manufacturing Facility. The department performs analytical testing on intermediate, inprocess and final product materials using a variety of equipment to include GC, FTIR, UVVIS, and physical property instrumentation.
This position is responsible for performing routine to complex techniques associated with daily QC release and provides an investigative or technological orientation in implementing, executing and interpreting quality procedures and test methods.
Supports Biosurgery Business by performing in-process, stability and release testing for Biosurgery Product lines.
- Perform Assays in accordance with SOP’ s for release, stability and in-process samples.
- Review peer data including data transcription, data calculation and log entries.
- Initiate DCR’ s as required. Manage Periodic review program for group.
- Train on all documents assigned to training plan.
- Perform or participate in Equipment Qualifications.
- Support Method Validations.
- Complete training as assigned.
- Author technical reports.
- Bring in new equipment (spec, URS, etc.).
- Conduct department walkthroughs.
- Review and approve control trends.
- Schedule coordinator.
- Complete effectiveness reviews.
- CAPA plans, assignments, closure.
- Maintain deviation/CAPA/Task/CCR database to help drive closure.
- Investigate Deviations.
- Attend Deviation Meetings.
- Responsible for adherence to policies, procedures and SOP’ s.
- Participate and approve lab investigations.
- Adhere to site Quality and Safety Policies.
- Work toward accomplishment of Site Goals.
- Perform OOS investigations.
- Participate in audits.
- Create/review Certificates of Analysis
- Support applicable department or organizational metrics.
- Experience in laboratory techniques such as: pH, GC, UV/VIS and FTIR. Technical writing and Assay validation experience.
- Technical experience in problem solving analytical methods and strong attention to details
- Bachelor’ s degree or equivalent in science.
- 5-8 years lab experience.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.